FDA.reportPublic FDA data

Spaced out

Product NDC
57955-1541
11-digit product format
579551541
Labeler code
57955
Product ID
57955-1541_0f193056-44b0-423e-89f8-31e49cf813a2
Type
HUMAN OTC DRUG
Nonproprietary name
Asarum europaeum, Clematis erecta, Clematis vitalba, flos, Cocculus indicus, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Naja tripudians, Nux moschata, Oleander, Rosa damascena, Rosmarinus officinalis, Stigmata maidis, Sulphur
Dosage form
LIQUID
Route
ORAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-03-14
Marketing end
0000-00-00
Substance
ASARUM EUROPAEUM; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; ANAMIRTA COCCULUS SEED; LATHYRUS SATIVAS SEED; LONICERA CAPRIFOLIUM FLOWERING TOP; ACHILLEA MILLEFOLIUM; NAJA NAJA VENOM; NUTMEG; NERIUM OLEANDER LEAF; ROSA DAMASCENA FLOWERING TOP; ROSMARINUS OFFICINALIS FLOWERING TOP; CORN SILK; SULFUR
Active strength
10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-1541-22020-01-31C16284748780-19d75b9d0-3da5-f424-e053-dadaa90a57ceSpaced Out™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-1541-2Spaced out59 mL in 1 BOTTLE, SPRAYLIQUID594

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACHILLEA MILLEFOLIUMACTIVE INGREDIENT2FXJ6SW4PKSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
ANAMIRTA COCCULUS SEEDACTIVE INGREDIENT810258W28USPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
ASARUM EUROPAEUMACTIVE INGREDIENTH0876AL67ASPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
CLEMATIS RECTA FLOWERING TOPACTIVE INGREDIENT396421SP9FSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
CLEMATIS VITALBA FLOWERACTIVE INGREDIENT7SCP4N87CISPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
CORN SILKACTIVE INGREDIENT7D3VB244UXSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
LATHYRUS SATIVAS SEEDACTIVE INGREDIENT8VP54WOT4ISPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
LONICERA CAPRIFOLIUM FLOWERING TOPACTIVE INGREDIENT1X0T378SXYSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
NAJA NAJA VENOMACTIVE INGREDIENTZZ4AG7L7VMSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
NERIUM OLEANDER LEAFACTIVE INGREDIENT7KV510R6H6SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
NUTMEGACTIVE INGREDIENTAEE24M3MQ9SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
ROSA DAMASCENA FLOWERING TOPACTIVE INGREDIENT21W82Q764GSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
ROSMARINUS OFFICINALIS FLOWERING TOPACTIVE INGREDIENT8JM482TI79SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
SULFURACTIVE INGREDIENT70FD1KFU70SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
ACHILLEA MILLEFOLIUMACTIVE MOIETY2FXJ6SW4PKSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
ANAMIRTA COCCULUS SEEDACTIVE MOIETY810258W28USPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
ASARUM EUROPAEUMACTIVE MOIETYH0876AL67ASPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
CLEMATIS RECTA FLOWERING TOPACTIVE MOIETY396421SP9FSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
CLEMATIS VITALBA FLOWERACTIVE MOIETY7SCP4N87CISPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
CORN SILKACTIVE MOIETY7D3VB244UXSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
LATHYRUS SATIVAS SEEDACTIVE MOIETY8VP54WOT4ISPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
LONICERA CAPRIFOLIUM FLOWERING TOPACTIVE MOIETY1X0T378SXYSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
NAJA NAJA VENOMACTIVE MOIETYZZ4AG7L7VMSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
NERIUM OLEANDER LEAFACTIVE MOIETY7KV510R6H6SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
NUTMEGACTIVE MOIETYAEE24M3MQ9SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
ROSA DAMASCENA FLOWERING TOPACTIVE MOIETY21W82Q764GSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
ROSMARINUS OFFICINALIS FLOWERING TOPACTIVE MOIETY8JM482TI79SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
SULFURACTIVE MOIETY70FD1KFU70SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-1541SPACED OUT (ASARUM EUROPAEUM, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, LATHYRUS SATIVUS, LONICERA CAPRIFOLIUM, FLOS, MILLEFOLIUM, NAJA TRIPUDIANS, NUX MOSCHATA, OLEANDER, ROSA DAMASCENA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR) LIQUID [KING BIO INC.]4Legacy NDC, 1 package rows20180314_27b68f42-63ee-486f-8779-4eb6ad62031c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57955-1541-25795515410259 mL in 1 BOTTLE, SPRAY59 mlHistorical